Suture, Absorbable

FDA Pre-Market Approval

FDA Class 2 ·COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA

DIAGNOSOFT HARP

FDA 510(k)

FDA Class 2 ·Radiology

ROCATEC(R) -PLUS

FDA 510(k)

FDA Class 2 ·Dental

SONO(R) -CEM

FDA 510(k)

FDA Class 2 ·Dental

ESPE(R) -SIL

FDA 510(k)

FDA Class 2 ·Dental

BEBIG PLAQUES RUM101-RUM114

FDA 510(k)

FDA Class 2 ·Radiology

BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

FDA 510(k)

FDA Class 2 ·Cardiovascular

CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR

FDA 510(k)

FDA Class 2 ·Microbiology

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

FDA 510(k)

FDA Class 2 ·Microbiology

Visualase V2 MRI-guided Laser Ablation System (9736422)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monteris Medical NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANBERG Thermoguide Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BowTie™ SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTAL RADIO-ULNAR JOINT IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

QUAD-LINK RETRACTABLE MOUNT

FDA 510(k)

FDA Class 2 ·Physical Medicine

NilRead

FDA 510(k)

FDA Class 2 ·Radiology